MathWorks today announced that TÜV SÜD certified Simulink Verification and ValidationTM (transitioned at R2017b), Simulink Design VerifierTM, Simulink TestTM, Embedded Coder®,and Polyspace® as suitably validated for use in IEC 62304 compliant development processes. This independent assessment offers medical device design engineers increased confidence when using MathWorks Model-Based Design tools for IEC 62304 standard and FDA certification development processes.
In addition to ISO 26262, IEC 61508, and EN 50128, MathWorks IEC Certification Kit now includes certificates for the IEC 62304 standard, which guides medical device software development processes. Now, engineers and researchers using Model-Based Design for medical device embedded software development can use artifacts provided in the IEC Certification Kit directly as an integral part of their tool validation plan.
With MathWorks successful completion of an audit by TÜV, organizations can now use the certification kit artifacts as evidence of compliance with IEC 62304 for Model-Based Design tools, including:
- Simulink Verification and Validation for automating requirements tracing, modeling standards compliance checking, and model coverage
- Simulink Design Verifier for generating test cases that satisfy structural coverage objectives
- Simulink Test for developing, managing, and executing tests during simulation and processor-in-the-loop (PIL)
- Embedded Coder for generating production quality code for field deployment
- Polyspace Bug Finder and Polyspace Code Prover for formal verification of hand-written and generated code
“Given the regulatory certification and compliance requirements medical device manufacturers need to meet, they are increasingly relying on Model-Based Design to help them simplify and perfect complex workflows,” said Arvind Ananthan, medical devices industry manager, MathWorks. “By offering IEC 62304 validated tools, MathWorks strengthens efforts to help these engineers reduce time and effort spent on tool validation, allowing them to focus on design iteration and development quality.”